Time release sleep aid system

Abstract

Compositions for treating a sleep disorder or modifying or improving the sleep-wake cycle in a subject are disclosed herein. In some examples, the composition can comprise one or more sleep promoting active agents, one or more sleep quality active agents, one or more sleep recovery active agents, and optionally one or more next day active agents. The composition can provide an immediate burst release of the one or more sleep promoting active agents, a delayed burst or delayed sustained release of the one or more sleep quality active agents, a delayed burst or delayed sustained release of the one or more sleep recovery active agents, and a delayed burnt or delayed sustained release of the one or more next day active agents. The composition can be provided as a daily oral uni-dosage form. Methods of making and using the compositions are also provided.

What is claimed is: 
     
       1. A delivery capsule comprising:
 a) one or more sleep promoting active agents having immediate burst release within about 30 minutes of administration of the capsule, and 
 b) one or more sleep quality active encapsulated by a polymeric binder having delayed release from about 1 hour to about 6 hours after administration of the capsule, 
 wherein the polymeric binder delays release of the one or more sleep quality active agents until from about 1 to about 6 hours after administration of the capsule, and 
 wherein each active agent is independently a phytochemical, an herbal extract, a vitamin, a hormone, an amino acid, a mineral, and combinations thereof. 
 
     
     
       2. The delivery capsule of  claim 1 , wherein delayed release of the sleep quality active agents is selected from a delayed burst release, a delayed sustained release, and combinations thereof. 
     
     
       3. The delivery capsule of  claim 1 , wherein delayed release of the sleep quality active agents comprises a delayed sustained release of the sleep quality active agents. 
     
     
       4. The delivery capsule of  claim 1 , wherein delayed sustained release of at least a portion of the sleep quality active agents is within 2 to 5 hours of administration. 
     
     
       5. The delivery capsule of  claim 1 , wherein the sleep quality active agent has a sustained release of 2.5-4.5 hours. 
     
     
       6. The delivery capsule of  claim 1 , wherein the composition includes at least two sleep promoting active agents selected from the group consisting of melatonin, casein decapeptide, L-tryptophan, and magnesium. 
     
     
       7. The delivery capsule of  claim 1 , wherein the composition includes at least two sleep quality active agents selected from the group consisting of Valerian root extract, hops extract, lemon balm extract, melatonin, and an extract from Magnolia. 
     
     
       8. The delivery capsule of  claim 1 , wherein the composition includes at least two sleep quality active agents selected from the group consisting of Valerian root extract, hops extract, lemon balm extract, and melatonin. 
     
     
       9. The delivery capsule of  claim 1 , wherein the one or more sleep quality active agents are in an amount of from about 0.5 wt % to about 55 wt %, based on the combined weight of the sleep quality active agents and the polymeric binder. 
     
     
       10. The delivery capsule of  claim 1 , wherein the capsule further comprises one or more sleep recovery active agent and/or one or more next day active agents having delayed release after about 6 hours from administration of the capsule. 
     
     
       11. The delivery capsule of  claim 10 , wherein the one or more sleep recovery active agents when present, are selected from the group consisting of L-theanine, L-taurine, γ-aminobutyric acid, glycine, folic acid, (6S)-5-methyltetrahydrofolic acid or a salt thereof, inositol, riboflavin 5′-phosphate or a salt thereof, vitamin A, vitamin B12, methylcobalamin, cyanocobalamin, vitamin B3, vitamin B5, vitamin B6, pyridoxine, vitamin B9, vitamin C, vitamin D3, a xanthine, carnosine, alpha-glycerylphosphoryl choline, lecithin, cytidine diphosphate choline, phosphatidyl serine, ATP, ribose, magnesium, coenzyme Q10, extract from  Coleus forskohlii , extract from  Bacopa monnieri , caffeine, ephedra, vincamine, cocoa extract, extract from  Ginkgo biloba, Panax ginseng , extract from  Eleutherococcus senticosus , extract from  Centella asiatica , peppermint extract, rosemary extract, wild oats extract, blends thereof, and combinations thereof.